Krystal Biotech, Inc.
Form 483 issued November 16, 2022 · Pittsburgh, Pennsylvania
- Inspection
- Nov 11 – Nov 16, 2022
- Investigators
- Anna Kwilas· Bo Liang· Carl Perez
- Observations
- 4
- Pages
- 2
- FEI number
- 3013498720
In short: On November 16, 2022, FDA issued a Form 483 with 4 observations to Krystal Biotech, Inc. in Pittsburgh, Pennsylvania (FEI 3013498720) after an inspection that ran Nov 11 – Nov 16, 2022. The investigators were Anna Kwilas, Bo Liang, Carl Perez, Jianyang Wang, Priscilla M. Pastrana and Wei Wang. Most observations concern quality system and production; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Observations span 4 systems, led by quality system.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Drug product production and control records are not reviewed and approved by the quality control unit…
- 02
Procedures designed to prevent objectionable microorganisms in drug substance _ _ _ _(b_) _(4)…
- 03
Observation 3: scanned text, readable in the full document.
- 04
There is no on incoming starting materials…
This inspection in context
Anna Kwilas
3 documents · 2022–2024
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmKrystal Biotech, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Krystal Biotech, Inc.?
FDA listed 4 observations on this Form 483, mostly about quality system, production and facilities & equipment. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Krystal Biotech, Inc.?
Anna Kwilas, Bo Liang, Carl Perez, Jianyang Wang, Priscilla M. Pastrana and Wei Wang are named on this Form 483, for the inspection of Nov 11 – Nov 16, 2022. Each investigator has a profile showing what they cite most.
When was Krystal Biotech, Inc. inspected by FDA?
The inspection ran Nov 11 – Nov 16, 2022, and the Form 483 is dated November 16, 2022.
How do I get the full Form 483 for Krystal Biotech, Inc.?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.